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Surgical Suction Tip

by Tlc Medservices, Inc.

510(k) K932185

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932185 Date27 Oct 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOL
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A surgical suction tip is a catheter and tip device used for suction in medical procedures. It is designed to remove fluids, debris, or other materials from a surgical site during operative interventions.

This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is regulated as a Class II medical device under FDA 510(k) clearance K932185, with product code JOL, and is indicated for use in general hospital settings.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the surgical suction tip used for?

    The surgical suction tip is a catheter and tip device used for suction in medical procedures. It is designed to remove fluids, debris, or other materials from a surgical site during operative interventions, making it suitable for general hospital settings where fluid clearance is needed during surgery.

  • Is the surgical suction tip sterile or non-sterile when supplied?

    The surgical suction tip is supplied non-sterile. It is intended for reusable use after appropriate cleaning and sterilization by the user, meaning the end-user must perform sterilization prior to each use according to their facility's protocols.

  • Can the surgical suction tip be reused, and what processing is required?

    Yes, the surgical suction tip is intended for reusable use. It must be cleaned and sterilized by the user after each use, as it is supplied non-sterile. Reuse is only appropriate following validated cleaning and sterilization procedures to ensure patient safety and device integrity.

  • What regulatory pathway was used for the surgical suction tip?

    The surgical suction tip is regulated as a Class II medical device under FDA 510(k) clearance K932185. It was found substantially equivalent to a predicate device, with product code JOL, and received traditional clearance on October 27, 1993, after submission on May 5, 1993.

  • Who manufactures the surgical suction tip and where is it based?

    The surgical suction tip is manufactured by Tlc Medservices, Inc., located at 1988 Suwanee Robert Ct., Lawrenceville, GA 30243, United States. The applicant and manufacturer information is consistent across the device’s regulatory filing.